Continuous glucose monitors (CGMs) play a central role in diabetes management, influencing insulin dosing and powering automated systems. For people dosing insulin, CGM data directly impacts safety, yet testing standards used to evaluate these devices vary widely and often go unquestioned.

In Europe, CE marking allows devices to reach the market without consistent study requirements or defined accuracy thresholds, with some systems still based on frameworks from 1993. In the U.S., iCGM classification sets stricter standards, requiring full-range testing and strong accuracy performance. Systems from Dexcom, Abbott, and Eversense currently meet those standards.

These differences are already showing real-world impact, from CGM product backlash to safety concerns tied to automated insulin delivery (AID) systems in Europe.

In our latest podcast episode, we sit down with John Pemberton, founder of Glucose Never Lies and a dietitian at Birmingham Children's Hospital, to break down what CE marking actually means, why it falls short of FDA and iCGM standards, and what every person with diabetes should be asking before trusting their CGM data. Listen above or watch below.

Be sure to subscribe to the Diabetech Podcast on Spotify, Apple Podcasts, or Youtube.

Disclaimer: Diabetech content is not medical advice—it’s for educational purposes only. Always consult with a physician before making changes to your healthcare.